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Effects of a Self-Management Group-Intervention on Participation in Post-Stroke Patients.

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ClinicalTrials.gov Identifier: NCT02289287
Recruitment Status : Recruiting
First Posted : November 13, 2014
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Stroke is defined as a sudden vascular accident that causes brain damage and neurological impairment. Literature shows that a stroke has a negative effect on participation. Self-Management (SM) is defined as health promotion and education programs used mostly for people with chronic diseases, which aim at helping patients to maintain a feeling of wellness. The primary aim of this study is to assess the effectiveness of a group-based SM program for post-stroke patients in a community setting, and its contribution to improving participation, compared to standard care.

Condition or disease Intervention/treatment
Stroke Behavioral: Self-Management group-intervention Behavioral: Standard Care

Detailed Description:
At enrollment eligible patients will be randomized to Intervention + Standard Care or Standard Care group. Within 3 weeks after enrollment all participants will undergo baseline assessment using a predefined set of scales and questionnaires (intervention group will additionally undergo a semi-structured interview). The group-intervention (SM program) will begin after enrollment of at least 4 participants to the intervention group, and within no longer than 5 weeks since enrollment. The intervention will include 12 weekly sessions, each session 2.5 hour long, and will be based on well-known SM interventions that were found effective for stroke patients in the U.S. Standard care will include 'one-on-one' sessions in each paramedical discipline as given regularly in this setting (average of 15-20 sessions per patient). Follow-up measures will be performed within a week after the end of the intervention, and 6 months thereafter, in order to examine long term effectiveness. Outcome measures are questionnaires; change will be assessed by the difference in total score between T1 |(pre-intervention), T2 (post-intervention) and T3 (after 6 months)

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Self-Management Group-Intervention on Participation in Post-Stroke Patients.
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017
Arms and Interventions

Arm Intervention/treatment
Experimental: Self-Management group-intervention
Participants will receive Self-Management group-intervention + Standard Care
Behavioral: Self-Management group-intervention
At enrollment eligible patients will be randomized to Intervention + Standard Care or Standard Care group. Within 3 weeks after enrollment all participants will undergo baseline assessment using a predefined set of scales and questionnaires (intervention group will additionally undergo a semi-structured interview). The group-intervention (SM program) will begin after enrollment of at least 4 participants to the intervention group, and within no longer than 5 weeks since enrollment. The intervention will include 12 weekly sessions, each session 2.5 hour long, and will be based on well-known SM interventions that were found effective for stroke patients in the U.S. Follow-up assessments will be done at 12 and 36 week to examine long term effectiveness.
Active Comparator: Standard Care
Participants will receive Standard Care only
Behavioral: Standard Care
At enrollment eligible patients will be randomized to Intervention + Standard Care or Standard Care group. Within 3 weeks after enrollment all participants will undergo baseline assessment using a predefined set of scales and questionnaires (intervention group will additionally undergo a semi-structured interview). Standard care will include 'one-on-one' sessions in each paramedical discipline as given regularly in this setting (average of 15-20 sessions per patient). Follow-up assessments will be done at 12 and 36 week to examine long term effectiveness.


Outcome Measures

Primary Outcome Measures :
  1. Patient Participation [ Time Frame: 12 and 36 weeks ]
    The primary outcome measure is the change in patient's participation, as defined by the International Classification of Function, Disability and Health (ICF), between the three assessment points - baseline, 12 and 36 weeks.


Secondary Outcome Measures :
  1. Self-efficacy for self-management behaviors. [ Time Frame: 12 and 36 weeks ]
    Self-efficacy for self-management behaviors.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Cerebrovascular accident diagnosed 3-18 months before enrollment. Treated at th Neurologic Rehabilitation Center of Clalit Health Services in Kiryat Byalik, Israel.

Living in the community (in their homes). Are capable of basic communication in Hebrew.

Exclusion Criteria:

Moderate-severe stroke (National Institutes of Health Stroke Scale (NIHSS) score ≤ 16).

Moderate-Severe Cognitive impairment (Montreal Cognitive Assessment (MOCA) - total score ≤ 16). Inability to provide informed consent.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289287


Contacts
Contact: Uzi Milman, MD 972-50-6261360 uzimy@netvision.net.il
Contact: Hagit Harel-Katz, B.OT, M.Sc 972-54-4415312 hagitrl4@gmail.com

Locations
Israel
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, Recruiting
Haifa,, Israel
Contact: Uzi Milman, MD    972-50-6261360    uzimy@netvision.net.il   
Sub-Investigator: Uzi Milman, MD         
Sponsors and Collaborators
Uzi Milman
University of Haifa
Investigators
Principal Investigator: Tamar Adar, MD Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
Study Chair: Eli Carmeli, PhD Department of Physical Therapy, Faculty of Social Well fare and Health Sciences, Haifa University, Haifa, Israel.
Principal Investigator: Hagit Harel-Katz, MSc Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
Study Director: Uzi Milman, MD Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL
More Information

Responsible Party: Uzi Milman, Director, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District and the Department of Family Medicine, Faculty of Medicine, Technion- Israel Institute of Technology, HAIFA, ISRAEL, Clalit Health Services
ClinicalTrials.gov Identifier: NCT02289287     History of Changes
Other Study ID Numbers: COM - 0018-14-CTIL
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Uzi Milman, Clalit Health Services:
Self-Management
Stroke
Intervention
Group Processes

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases